A Pilot Study of Fluconazole Plus Flucytosine for the Treatment of AIDS Patients With Acute Cryptococcal Meningitis.

This study has been completed.

Sponsor:

Pfizer

ClinicalTrials.gov Identifier:

NCT00002113

First Posted: August 31, 2001

Last Update Posted: March 17, 2014

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To evaluate and estimate the safety and efficacy of the combination of fluconazole and flucytosine as treatment for acute cryptococcal meningitis in patients with AIDS.

Fluconazole and flucytosine have different mechanisms of action. Since fluconazole has not been associated with hematologic suppression and does not produce renal impairment that can result in higher serum flucytosine levels, this combination may be better tolerated than is amphotericin B plus flucytosine.

Fluconazole and flucytosine have different mechanisms of action. Since fluconazole has not been associated with hematologic suppression and does not produce renal impairment that can result in higher serum flucytosine levels, this combination may be better tolerated than is amphotericin B plus flucytosine.

Patients in each cohort receive a lower dose of fluconazole alone or in combination with flucytosine, or a higher dose of fluconazole alone. Doses in subsequent cohorts are escalated if safety data in the previous cohort is satisfactory. Patients are evaluated weekly for the first 4 weeks and every 2 weeks thereafter. Therapy continues until 8 weeks after the CSF becomes culture negative, up to a maximum of 26 weeks.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

13 Years and older (Child, Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

Antiviral therapy (AZT, DHPG).

Prophylaxis for Pneumocystis carinii pneumonia.

Treatment for intercurrent opportunistic infection.

Concurrent Treatment:

Allowed:

Radiation therapy for mucocutaneous Kaposi's sarcoma.

Patients must have:

AIDS.

Evidence of Cryptococcal neoformans in culture or lumbar CSF OR clinical and CSF findings compatible with cryptococcal meningitis.

No evidence of acute or chronic meningitis of any etiology other than cryptococcosis.